Prospective Evaluation of the Use of Intralesional Cryotherapy for Treatment of Keloid and Hypertrophic Scars

This study has been completed.
Sponsor:
Collaborator:
Red Cross Hospital Beverwijk
Information provided by (Responsible Party):
Michiel van Leeuwen, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01994616
First received: November 19, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types.


Condition Intervention
Keloid
Cicatrix, Hypertrophic
Procedure: Intralesional cryotherapy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Intralesional Cryotherapy for Treatment of Keloid Scars: a Prospective Evaluation

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • Recurrence [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
    Judgment of recurrence, defined as a growing, pruritic, nodular scar


Secondary Outcome Measures:
  • Scar elasticity [ Time Frame: 0-12months ] [ Designated as safety issue: No ]
    Scar elasticity, measured in two parameters: extension and elasticity


Other Outcome Measures:
  • Scar volume [ Time Frame: 0-12months ] [ Designated as safety issue: No ]
    Determined by creating a mold of the scar with dental putty

  • Redness (erythema) and pigmentation (melanin), [ Time Frame: 0-12months ] [ Designated as safety issue: No ]
    Redness (erythema) and pigmentation (melanin), which were measured using the DermaSpectrometer

  • Subjective scar evaluation [ Time Frame: 0-12months ] [ Designated as safety issue: No ]
    performed by two experienced medical doctors and the patient using the Patient and Observer Scar Assessment Scale (POSAS). Each item of the POSAS was scored using a 10-step score, in which 10 reflected 'worst scar imaginable' and 1 indicated 'normal skin'


Enrollment: 30
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
keloid or hypertrophic scars
All patient including all skin types with keloid or hypertrophic disease receiving Intralesional Cryotherapy
Procedure: Intralesional cryotherapy
Intralesional (IL) cryotherapy is a treatment for keloids and hypertrophic scars, in which the scar is frozen from inside with the use of a cryoneedle
Other Name: Cryoneedle (CryoShape, Etgar Group International Ltd, Kfar Saba, Israel)

Detailed Description:

Intralesional (IL) cryotherapy is a novel treatment for keloids and hypertrophic scars, in which the scar is frozen from inside. Published results are promising, however only Caucasian patient populations have been studied. This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of mixed Fitzpatrick skin types. All patients with keloid or hypertrophic scars meeting inclusion criteria were treated with a liquid nitrogen based device called Cryoshape Scar quality and possible recurrence are assessed pre- and postsurgery (3, 6 and 12 months) with objective devices determine scar color, scar elasticity, scar volume and patient's skin type. In addition, scars are evaluated using the Patient and Observer Scar Assessment Scale.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A mixed patient population with all Fitzpatrick skin types

Criteria

Inclusion Criteria:

  • Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion
  • Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr)
  • A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks
  • Patients with all Fitzpatrick17 skin types
  • Patients older than 10 years of age

Exclusion Criteria:

  • pregnancy
  • diabetes mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994616

Locations
Netherlands
VUmc
Amsterdam, Noord-Holland, Netherlands, 1081HV
Sponsors and Collaborators
VU University Medical Center
Red Cross Hospital Beverwijk
Investigators
Principal Investigator: Michiel CE van Leeuwen, MD VUmc
Study Director: Frank B Niessen, PhD, MD Vumc
  More Information

Additional Information:
Publications:
Responsible Party: Michiel van Leeuwen, Medical Doctor, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01994616     History of Changes
Other Study ID Numbers: 12/292
Study First Received: November 19, 2013
Last Updated: November 19, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by VU University Medical Center:
Keloid, hypertrophic scar

Additional relevant MeSH terms:
Hypertrophy
Keloid
Cicatrix, Hypertrophic
Cicatrix
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014